1. Field of the Invention
The present invention relates to a method for counteracting adverse drug events (ADE's) which are caused by the administration of intravenous medications of incorrect types, concentrations or dosages, and which may result in morbidity and even mortality to recipient patients. The invention is further directed to an apparatus for the counteraction of adverse drug events of the types described herein.
In accordance with current statistics which have been compiled by the Institute for Health Care Improvement, adverse drug event injuries caused by the intravenous administering of incorrect or improperly dosed and/or concentrated medications are a major cause of disabilities encountered by hospitalized patients. In the United States alone, adverse drug event effects are considered to affect as many as 770,000 to possibly two million patients annually, at costs which are estimated to be approximately 4.2 billion dollars, with as many as half of all adverse drug event injuries being considered as having been caused by administering errors and, consequently, deemed to be preventable in nature. These errors in the improper or erroneous intravenous administration of medication are calculated to engender costs of approximately $4,685.00 for each patient, and to increase the average length of a hospital stay by two days, with such adverse drug event injuries being normally encountered in virtually every hospital or similar health related facility.
The majority of serious injuries resulting from adverse drug events pertain to the utilization of intravenous medications which are added to an infusion of dextrose in water or saline solution. Unless a patient is highly allergic, one or two doses of an erroneously administered oral medication would be unlikely to result in significant morbidity, whereas, on the other hand, a single dose of an intravenous medication; for example, such as potassium, could be fatal in nature if inadvertently administered to a patient who is subject to renal failure. The vast majority of intravenous additives are clear and colorless, as a result of which it is not readily possible to ascertain as to whether the proper medication or dosage of such medication was, in fact, added to the infusion. Basically, the only mechanism available for the prevention of errors is the basic assumption that the pharmacist has added the appropriate medication in the prescribed dosage to the infusion. Other potential errors can occur through the use of current methods of intravenously administrating such medications, in that the pharmacist, upon having added the medication, causes a label to be placed on the bag of the infusion with the name and dosage or degree of dilution of the medication. The label can conceivably fall off, be smudged or misinterpreted by a nurse or other medical personnel administering the infusion to the patient, with the resultant potential of an adverse drug event.
Although steps have been taken to minimize many of the potential errors caused by adverse drug events through joint efforts by the Food and Drug Administration, hospitals and the pharmaceutical industry, it would be highly advantageous to provide for the standardization of commonly utilized and potentially harmful additives. Among recent efforts are the color coding of these agents with food coloring, and the use of spectrophotometers to determine the nature and concentrations of the additives, with such technology being relatively inexpensive and commonly employed throughout industry and in medical laboratories. Thus, currently, various aspects of the technology which can be potentially applied to solving or at least considerably ameliorating the problems encountered with regard to adverse drug event injuries, can be ascertained in the state-of-the-art.
2. Discussion of the Prior Art
Among publications which are of interest with regard to the present inventive concept which is directed to eliminating or at least reducing the phenomenon of adverse drug events caused by the administration of intravenous medications of various types, concentrations or dosages; of particular interest is U.S. Pat. No. 5,468,224 to Souryal. This particular patent teaches the color coding of injectable medications which are most frequently intravenously administered, particular in the presence of emergency situations in which time is of the essence or critical in nature so as to necessitate immediate medical decisions. The injectable medications are color coded through the addition of harmless coloring materials to the medications, such as food coloring agents, wherein each particular medication is assigned a specific standardized color or, alternatively, a particular class of medications is assigned a specific color. In this particular instance, the patent does not teach or take into consideration the concentration of such injectable medication based on color concentrations, and this would not preclude the inadvertent infusion of dosages of medications which have been incorrectly added to an infusion of a saline or similar basic infusion.
U.S. Pat. No. 5,510,621 to Goldman discloses the utilization of an analyzer employing near-infrared spectrophotometric techniques for determining the concentration of colorless components used in the make-up of an infusion, such as parenteral nutrients,; e.g., in an intravenous bag. However, in this particular patent there is also a brief but undeveloped suggestion that spectrophotometric techniques in the visible light region can be used to determine concentrations of material. Other spectrophotometric and spectroscopic methods have been employed in various modes in order to determine concentrations of colored chemical samples and physiological samples; for example, in blood or other liquid media; referring for instance, to U.S. Pat. No. 4,193,694 to Smith; U.S. Pat. No. 4,935,875 to Shah et al.; and U.S. Pat. No. 4,997,769 to Lundsgaard. None of these patents teach the utilization or requirement of the addition of dye materials in order to facilitate photometric concentration analysis.
U.S. Pat. No. 5,563,031 to Yu discloses the use of adding a dye coupling compound in a reagent system having an analyte whose presence is to be measured and which reacts to form colored chromophores in amounts indicative of the quantity of the analyte contained in the system.
U.S. Pat. No. 5,298,428 to O'Rourke, et al. teaches that non-photoreactive chemical samples whose concentrations are to be determined can be readily mixed with an indicative dye so as to render them photoreactive, and thereby consequently facilitating the determination of their concentrations utilizing spectrophotometric techniques.
Finally, of general interest are the disclosures of U.S. Pat. Nos. 5,267,178 to Berner and 5,400,138 to Peterson, et al. which, respectively, describe computer control techniques and intelligent spectrophotometric devices employed for color measurement purposes.
Although coloring materials for medications have been employed in order to assist medical personnel in emergency situations, to date there has not yet been derived an effective method for safeguarding against adverse drug event (ADE) injuries, nor has there been any suggestion or disclosure of employing the addition of coloring materials to medications for utilization in intravenous administrative applications in order to verify the concentration of a desired medication.